BEUDAMED
    FDA Enforcement Class II Terminated

    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    Recall: Z-1342-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1342-2018
    Event ID
    79077
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 18, 2018
    Initiation Date
    February 5, 2018
    Classification Date
    April 10, 2018
    Termination Date
    September 17, 2019
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    Reason

    The infusion sets were manufactured with an incorrect spin collar.

    Code Info

    Lot numbers 3474877, UDI (01) 0 0887709 074578 (30) 500 (10)3474877; and Lot number 3481246, UDI (01) 0 0887709 074578 (30) 500 (10) 3481246.

    Distribution

    Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.

    Quantity

    11,500 pouches